Research Involving Human and Animal Subjects

Human Subjects

Research involving human subjects conducted under the auspices of Arizona State University (ASU) is reviewed by the University Human Subjects Institutional Review Board (IRB) in compliance with federal regulations. Research involving human subjects concerns the collection of data on subjects whose performance of any activity is required for the purpose of compiling data. This includes data obtained by observation, interview, questionnaire, experiment, or a secondary source. Documents containing any data collection from human subjects require that applications be submitted to the University Human Subjects IRB for approval before data collection or recruitment of subjects is initiated. For further information, contact the human research coordinator in the Office of Human Research Administration at 480- 965-6788 or visit researchintegrity.asu.edu/humans.

Animal Subjects

Research involving the use of animals conducted under the auspices of Arizona State University is reviewed by the University Institutional Animal Care & Use Committee (IACUC) in compliance with federal regulations. Documents containing any data collection from animal research require that applications be submitted to the University Animal Care & Use Committee for approval. For further information, contact the IACUC secretary in the IACUC Office at 480-965-4387 or visit researchintegrity.asu.edu/animals. 

Collaborating With Other Institutions

When work involves researchers from multiple institutions under the purview of different IRBs, you may proceed in one of two ways:

1. Have each IRB review the submission independently. Your initial submission should only include ASU researchers and describe the scope of the project as ASU will be involved. Other researchers can then be added via a modification as their IRBs review and approve their role in the project.
2. Have one IRB serve as the IRB of record. This means that one IRB gives up oversight of the research activity to another IRB via an affiliation agreement. These agreements are designed to reduce duplication and increase efficiency by designating a single IRB review when more than one site is involved in a research project. The research team will need to contact each IRB to confirm that they are willing to defer review to a single IRB of record before submitting. Institutional officials at each IRB will then sign an affiliation agreement that you will need to submit according to their policies and procedures.

When another IRB is designated as the IRB of record, then the ASU IRB will rely on review, approval, and continuing oversight by the responsible IRB. After the external IRB has agreed to serve as the IRB of record, ASU will conduct a local context review. A local context review is required when ASU researcher(s) are engaged in human subjects research (through consenting, collecting data, or analyzing data).

ASU's review process is designed to efficiently assess the risk of a study to human subjects. Studies involving higher risk undergo greater scrutiny while low risk studies can be reviewed and approved more quickly. Some low risk studies can be reviewed and approved within 5-10 business days. Studies involving higher risk or studies specifically targeting projected populations like prisoners or Native Americans can take longer to approve.

Affiliation Agreements

In general, ASU is willing to sign affiliation agreements with most other qualified institutions. The ASU IRB will enter into affiliation agreements with other institutions based on recommendation and approval from the ASU Institutional Official. The institutions may cover single protocols or enter into general agreements for reciprocity between institutions. Once an affiliation agreement is finalized, the agreement is filed electronically. If you believe your research project requires a new affiliation agreement, please email research.integrity@asu.edu. 

ASU has standing "blanket" affiliation agreements with Northern Arizona University (NAU), University of Arizona, Mayo Clinic, Creighton University, Dignity Health, and Western Institutional Review Board—Copernicus Group (WCG). This means that there is no need for a formal IRB reliance agreement for every new project involving one of these institutions. However, ASU researchers are still required to submit to ASU IRB for a local contextual review for individual projects.

Affiliation agreements may be executed using either an Office for Human Research Projects (OHRP) template or within the Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB portal. If other qualified institutions prefer using the SMART IRB portal, then please review the SMART Reliance Agreement document for guidance on reliance requests through the SMART IRB. 

Required Training

The IRB of record will be responsible for determining what training is required. Other institutions will often accept ASU's IRB Collaborative Institutional Training Initiative Program (CITI) training if you have already completed it. 

Forms and Required Materials for a Local Context Review

When another IRB is designated as the IRB of record, then the ASU IRB will rely on the review, approval, and continuing oversight by the responsible IRB. After the external IRB has agreed to serve as the IRB of record, ASU will conduct a local context review which must include:

• A copy of the approved protocol, consent forms, instruments, and any other materials submitted.
• A completed copy of the Template: Local Context Review.
• A copy of the approval letter from the external IRB.
• ASU Federal-Wide Assurance (FWA) # ASU FWA 00009102.
• ASU FWA IRB Registration # IRB00000128.

Guidance for Research Involving Human Subjects and Secondary Data

What is secondary research?

• Secondary research refers to research using archival data or data that has already been collected by someone else. This type of research could also involve records, information or biospecimens that were collected for non-research purposes, such as materials that are left over from routine clinical diagnosis or treatments. Refer to 45 CFR 46.116(d) of the revised Common Rule.

When is secondary research considered human subjects research?

• The answer to this depends on the types of data that are being requested, how those data were obtained, how it is being assessed, and how it is being used. Secondary data must already be in existence at the time of submission. To protect researchers, the ASU IRB reviews all protocols involving the use of secondary data at individual level that include the intent to generalize knowledge from living individuals.
  • Individual vs. aggregate (group) level data:
    • If your analysis involves individual student educational records or individual patient records, then you are conducting secondary data analysis of records on an individual level. IRB review is required.
    • If your analysis involves data only in aggregate form, such as unemployment rates or infant mortality rates, then IRB review is not required.

Researchers who are unsure whether their project requires IRB review should contact the Office of Research Integrity and Assurance (ORIA) at research.integrity@asu.edu for consultation.

Research Involving Animals

ASU Animal Care and Use Program

Arizona State University is committed to the ethical and humane treatment of animals in advancing research that benefits humans, animals, and the environment. ASU's Animal Care and Use Program provides animal housing, husbandry and veterinary care; trains researchers on safe and ethical procedures; and ensures compliance with federal, state, and university regulations. This program has several components:

• Institutional Animal Care and Use Committee — Oversees a complaint and humane animal care and use program that supports the research and teaching programs of our researchers, instructors, and students.
• Department of Animal Care and Technologies — Provides exemplary care to all animals housed on campus and technical support to all investigators and instructors who use animals to advance education and knowledge.
• Animal Users Advisory Committee — Provides a conduit for communication between researchers and the animal care and use program as well as advises the program to ensure that it effectively addresses the needs of the researchers.

The ASU Animal Care and Use Program has an assurance on file with the Office of Laboratory Animal Welfare, is registered with the United States Department of Agriculture Animal and Plant Health Inspection Service (APHIS), and is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International.

Placement of Compliance Documentation for Research Involving Human (IRB) or Animal (IACUC) Subjects

Please place an IRB or IACUC approval letter in the APPENDIX section of the document. We recommend students take a screenshot of the approval letter and paste it into an appendix within the left/right 1.25-inch margins and top/bottom 1-inch margins. Further IRB or IACUC documentation that may be required includes affiliation agreements, exemption forms, or documentation regarding any modifications.

If a student conducted research and received IRB or IACUC approval at another institution and only analyzed de-identified data at Arizona State University, they need to provide the approval documentation received at that institution. They should also reach out to asuirb@asu.edu or iacuc@asu.edu to confirm if any additional documentation from the ASU IRB or ASU IACUC is necessary.

If a student has questions about what documentation to provide, please refer them to asuirb@asu.edu for research involving human subjects or iacuc@asu.edu for research involving animals.